Efficacy of a Nasal Spray Containing Iota-Carrageenan in the Prophylaxis of COVID-19 Disease in Health Personnel Dedicated to Patients Care With COVID-19. Multicenter, Randomized, Double-blind, Placebo-controlled Trial (CARR-COV-02)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- diagnose of COVID19 disease
研究概览
简要总结
Coronaviruses are enveloped viruses with an RNA genome. Carrageenans are sulfate polysaccharides synthesized by red algae. Studies conducted in adults and children with the common cold showed the effectiveness of the use of Carrageenan in nasal spray.
For decades, the antiviral action of Carrageenans has been described in numerous studies with different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency virus, human papillomavirus, H1N1 influenza virus, dengue virus, rhinovirus, hepatitis A virus, and enteroviruses. Studies on the dynamics of COVID-19 disease show an intense and rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the onset of pulmonary disease.
Finally, this molecule has shown a viricidal effect against SARS-Cov2 in vitro. All this underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled trial assessing the use a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 disease in health-workers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •physician, nurses, and physical therapist who usually attend hospitalized COVID19 patients.
- •No more than 48 hours since he/she assisted a COVID-19 patient
- •Able to understand and give written informed consent
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-19
- •Not having a cell phone with WhatsApp for remote monitoring
- •Hypersensitivity or known allergy to any component of the product
- •Pregnancy or lactation
研究组 & 干预措施
Control
Participants in this arm will receive a nasal spray with placebo
干预措施: Iota-Carrageenan (Drug)
Experimental
Participants in this arm will receive a nasal spray with Iota-Carrageenan
干预措施: Iota-Carrageenan (Drug)
结局指标
主要结局
diagnose of COVID19 disease
时间窗: 28 days
COVID 19 disease will be defined for clinical diagnose and positive Polymerase Chain Reaction test
次要结局
- lasting of disease(28 days)
- Progression to a more severe disease state, defined as need for oxygen therapy.(28 days)
- Incidence of COVID-19 disease onset in the first week after treatment(1 week after finishing treatment)
研究者
Ariel Dogliotti
PHYSICIAN
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno